Improving Core Outcome Set uptake in Physiotherapy trials

Awareness is growing of problems with the choice of outcomes to measure and report in trials, and the waste that this is causing. These include inconsistencies in what and how outcomes are measured across clinical trials; selective reporting of outcomes in some trials; and differences between the outcomes measured in trials and the outcomes that patients consider important.

One solution to these problems that is beginning to take hold is for clinical trialists in a particular topic area to measure and report, as a minimum, a core outcome set (COS). A COS is an agreed standardised collection of outcomes that should be measured and reported in a specific area of health.

This reduction in waste will only be realised however if researchers choosing outcomes for randomised controlled trials include COS in their studies. The continuous development of COS, without uptake, could itself result in research waste. Recent work has shown that uptake of COS is variable but generally still low [1 -3]. Research is needed to improve the uptake of COS.

About the project:

Phase 1 - To gain good understanding in this area, the student will undertake a methodological systematic review of available COS in Physiotherapy from the COMET database. This will serve as a benchmark of quality in COS development in Physiotherapy.

Phase 2 - Factors that affect the uptake of COS will be studied in detail, listing the possible barriers and facilitators. This will be done through a systematic review of literature following which a survey or interview with trialists and stakeholders will be done.

a. Trialists - what are the factors that influenced their decision to consider a COS, and their knowledge about the COMET database

b. Stakeholders - this will include the wider ecosystem of systematic reviewers, patients and patient organizations, clinical guideline and health technology assessment organizations to explore ways in their ability to promote COS uptake.

Phase 3 - Based on the findings, we would attempt to build a comprehensive conceptual framework for implementation. We would also use the Behaviour Change Wheel to study target behaviour, identify the relevant content, intervention and implementation options. According to the systems model, we could plan the implementation at different levels

a. Individual patient b. Health care professionals c. Organization d. National/International Regulations (World confederation of PT etc)

Once we establish the model, we would aim to evaluate the effectiveness, feasibility and acceptability of a particular intervention at different levels of implementation and disseminate findings to a wider audience. The different interventions may include involving the funders and trial regulators, and/or providing educational interventions to evaluate its effectiveness.

References:

1. Williamson PR, Barrington H, Blazeby JM, Clarke M, Gargon E, Gorst S, Saldanha IJ, Tunis S. (2022) Review finds core outcome set uptake in new studies and systematic reviews needs improvement. JCE 150: 154-164

2. Hughes KL, Clarke M, Williamson PR. (2020) A systematic review finds core outcome set uptake varies widely across different areas of health. Journal of Clinical Epidemiology, doi: https://doi.org/10.1016/j.jclinepi.2020.09.029

3. Hughes KL, Kirkham JJ, Clarke M, Williamson PR (2019). Assessing the impact of a research funder's recommendation to consider core outcome sets. PLoS ONE 14(9): e0222418. https://doi.org/10.1371/journal.pone.0222418